Recalls / Class III
Class IIID-854-2013
Product
Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36
- Affected lot / code info
- Lots: LF01643C, LF01644C, Exp 7/14
Why it was recalled
Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card
Recalling firm
- Firm
- Sandoz Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, N/A, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 8, 681 unit cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-08-07
- FDA classified
- 2013-08-08
- Posted by FDA
- 2013-08-14
- Terminated
- 2014-07-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-854-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.